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Irritable Bowel Syndrome With DiarrheaPhase 2NCT04129619

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

A Phase 2 study testing ORP-101 in people with Irritable Bowel Syndrome With Diarrhea, run by OrphoMed, Inc. at 74 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
ORP-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
74 sitesUnited States
Study dates
22 Nov 2019to 4 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to comply with protocol, including completion of electronic daily diary as required.
  • Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria, by history, for both IBS and IBS-D.
  • Has abdominal pain intensity score, and stool consistency as determined by protocol and assessed by Investigator for the week prior to randomization.
  • Has not used loperamide within the 14 days prior to randomization.
  • Is on a stable diet for the past 12 weeks and is not planning to change lifestyle and/or diet during study.

Who cannot join

  • History of clinically relevant pancreatic conditions including pancreatitis, pancreas divisum, or Sphincter of Oddi (SO) dysfunction with pancreatic manifestations.
  • History of biliary pathology including acute cholecystitis within 6 months or biliary pain including post-cholecystectomy pain.
  • Patients who have had biliary sphincterotomy with post-procedure persistent abnormal liver function transaminases (LFTs).
  • Planned elective surgery within the next 4 months.
  • Significant and/or severe medical illnesses such as cardiovascular, neurological, infectious, renal, hepatic or respiratory disorders that would interfere with the patient's medical care, participation in, or conduct of the study.
  • History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease).
Show all 12Show fewer
  • History of lactose intolerance uncontrolled on a lactose-free diet, or other malabsorption syndromes (e.g. fructose malabsorption).
  • Dysphagia or difficulty swallowing pills.
  • History of inflammatory bowel disease, celiac disease, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
  • History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred > 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred > 3 months prior to screening).
  • Patients >40 years of age at high risk for colon cancer must have had a screening colonoscopy within the past 3 years prior to trial screening visit or > 50 years of age, must have had a normal screening colonoscopy within the past 10 years prior to trial screening visit. Patients with Lynch Syndrome or Familial Polyposis are excluded from the study.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Synexus Clinical Research US, Inc. - Akron (Site 122)

    Akron, Ohio, 44311

  • Lovelace Scientific Resources Inc. (Site 176)

    Albuquerque, New Mexico, 87108

  • Agile Clinical Research Trials, LLC (Site 163)

    Atlanta, Georgia, 30328

  • Benchmark Research - Austin (Site 178)

    Austin, Texas, 78704

  • Northwest Clinical Research Center - ClinEdge (Site 148)

    Bellevue, Washington, 98007

  • Achieve Clinical Research (Site 155)

    Birmingham, Alabama, 35216

  • Northwest Clinical Trials - ClinEdge (Site 133)

    Boise, Idaho, 83704

  • Beth Israel Deaconess Medical Center (Site 115)

    Boston, Massachusetts, 02215

  • Imagine Research of Palm Beach County (Site 187)

    Boynton Beach, Florida, 33435

  • Connecticut Clinical Research Foundation (Site 136)

    Bristol, Connecticut, 06010

  • NY Scientific (Site 153)

    Brooklyn, New York, 11235

  • Investigators Research Group, LLC (Site 188)

    Brownsburg, Indiana, 46112

  • Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)

    Chandler, Arizona, 85224

  • OnSite Clinical Solutions, LLC - ClinEdge (Site 147)

    Charlotte, North Carolina, 28210

  • OnSite Clinical Solutions, LLC - ClinEdge (Site 146)

    Charlotte, North Carolina, 28277

  • WR-ClinSearch, LLC (Site 129)

    Chattanooga, Tennessee, 37421

  • Synexus Clinical Research US, Inc. - Chicago (Site 120)

    Chicago, Illinois, 60602

  • Hometown Urgent Care and Research (Site 150)

    Cincinnati, Ohio, 45215

  • Synexus Clinical Research US, Inc. - Cincinnati (Site 127)

    Cincinnati, Ohio, 45236

  • Gastrointestinal Diseases, Inc. Research (Site 137)

    Columbus, Georgia, 31904

  • Synexus Clinical Research US, Inc. - Columbus (Site 108)

    Columbus, Ohio, 43212

  • Hometown Urgent Care and Research (Site 149)

    Columbus, Ohio, 43214

  • Remington Davis Inc (Site 144)

    Columbus, Ohio, 43215

  • PriMed Clinical Research - ClinEdge (Site 121)

    Dayton, Ohio, 45419

  • Hometown Urgent Care and Research (Site 151)

    Dayton, Ohio, 45424

  • Synexus Clinical Research US, Inc. - Allaw (Site 102)

    Evansville, Indiana, 47714

  • Piedmont Research Partners LLC - BTC (Site 157)

    Fort Mill, South Carolina, 29707

  • Advanced Medical Trials (SIte 142)

    Georgetown, Texas, 78628

  • Long Island Gastrointestinal Research Group LLP (Site 107)

    Great Neck, New York, 11023

  • Synexus clinical Research US, Inc. - Greer (Site 105)

    Greer, South Carolina, 29651

  • Peters Medical Research, LLC - ClinEdge (SIte 111)

    High Point, North Carolina, 27262

  • Pioneer Research Solutions (Site 125)

    Houston, Texas, 77099

  • The Jackson Clinic PA - ClinEdge (Site 135)

    Jackson, Tennessee, 38305

  • Synexus Clinical Research US, Inc. - Queens (Site 119)

    Jamaica, New York, 11432

  • New Phase Research & Development (Site 181)

    Knoxville, Tennessee, 37909

  • Meridien Research - Lakeland (Site 167)

    Lakeland, Florida, 33803

  • Jubilee Clinical Research - BTC (Site 162)

    Las Vegas, Nevada, 89106

  • Sierra Clinical Research (Site 179)

    Las Vegas, Nevada, 89106

  • Precision Clinical Research LLC (Site 139)

    Lauderdale Lakes, Florida, 33319

  • Preferred Research Partners - ClinEdge (Site 103)

    Little Rock, Arkansas, 72211

  • Applied Research Center (Site 158)

    Little Rock, Arkansas, 72212

  • Meridien Research, Maitland - Inpatient (Site 141)

    Maitland, Florida, 32751

  • Synergy Group US, LLC - Missouri City - Hunt (Site 156)

    Missouri City, Texas, 77459

  • Exemplar Research, Inc. - Morgantown (Site 172)

    Morgantown, West Virginia, 26505

  • Synexus Clinical Research US, Inc. - Salt Lake City (Site 101)

    Murray, Utah, 84123

  • Mid Hudson Medical Research PLLC (Site 174)

    Newburgh, New York, 12553

  • Health Research of Hampton Roads Inc. (Site 173)

    Newport News, Virginia, 23606

  • Advanced Research Institute (Site 117)

    Ogden, Utah, 84405

  • Medical Research international (Site 180)

    Oklahoma City, Oklahoma, 73109

  • Synexus Clinical Research US, Inc. - Omaha (Site 113)

    Omaha, Nebraska, 68144

  • Oviedo Medical Research (Site 140)

    Oviedo, Florida, 32765

  • Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126)

    Papillion, Nebraska, 68046

  • DM Clinical Research - LinQ Research - ERN (Site 109)

    Pearland, Texas, 77584

  • The Center of Gastrointestinal Health (Site 152)

    Petersburg, Virginia, 23805

  • Tristar Clinical Investigations, P.C. (Site 168)

    Philadelphia, Pennsylvania, 19114

  • Elite Clinical Studies - Phoenix (Site 116)

    Phoenix, Arizona, 85018

  • Clinical Research Center of Florida (Site 186)

    Pompano Beach, Florida, 33060

  • AES-DRS-Synexus Clinical Research US, Inc.-Minneapolis (site 114)

    Richfield, Minnesota, 55423

  • PMG Research of Salisbury LLC (Site 110)

    Salisbury, North Carolina, 28144

  • Synexus Clinical Research US, Inc. - San Antonio (Site 112)

    San Antonio, Texas, 48229

  • Clinical Trials of Texas Incorporated - ClinEdge (Site 134)

    San Antonio, Texas, 78229

  • Meridian Clinical Research (Site 169)

    Savannah, Georgia, 31406

  • Sundance Clinical Research (Site 175)

    St Louis, Missouri, 63141

  • Meridien Research - St. Petersburg (Site 132)

    St. Petersburg, Florida, 33709

  • In Quest Medical Research, LLC (Site 131)

    Suwanee, Georgia, 30024

  • Del Sol Research Management - BTC (Site 165)

    Tucson, Arizona, 85712

  • Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118)

    Tucson, Arizona, 85741

  • Del Sol Research Management - BTC (Site 130)

    Tucson, Arizona, 85745

  • Frontier Clinical Research, LLC (Site 171)

    Uniontown, Pennsylvania, 15401

  • GNP Research (Site 145)

    Valdosta, Georgia, 31605

  • Alliance for Multispecialty Research, LLC (Site 159)

    Wichita, Kansas, 67207

  • Upstate Clinical Research Associates LLC - ClinEdge (Site 164)

    Williamsville, New York, 14221

  • PMG Research of Wilmington (Site 185)

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem (Site 124)

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ORP-101 in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.

Read the detailed description

The objectives of this study are to evaluate the efficacy, safety and tolerability of ORP-101 in patients with IBS-D. This is a randomized, double-blind, placebo-controlled, 3-arm, 12-week, parallel proof-of-concept study with 2 active arms (50 mg and 100 mg ORP-101, QD) and 1 matching placebo arm, using a responsive adaptive randomization approach. After screening, patients who qualify will enter the baseline symptom assessment period, during which they will be instructed on completion of an electronic diary for daily collection of data related to their IBS symptoms, bowel function and loperamide rescue usage (not allowed during baseline).

Patients who meet all entry criteria will be randomized to receive one of two different doses of ORP-101 tablets or placebo for 12 weeks. The study drug will be taken once daily, approximately 30 minutes prior to breakfast. Patients will return to the clinic on Days 14, 28, 56, 84 (12 weeks) and 2 weeks after dosing has completed (Day 98) for a follow-up visit.

Study subjects will include both male and female adults. Approximately 320 patients with IBS-D will be randomized to receive study drug or placebo. Randomization will be stratified by history of cholecystectomy/gallbladder agenesis.

Being tested
ORP-101, Placebo
Keywords
Irritable Bowel Syndrome, IBS
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORP-101Drug

    Also called dibuprenorphine-ethyl-ether

    Oral tablet

  • PlaceboDrug

    Oral tablet

Study groups in NCT04129619
Study groupRoleWhat they receive
ORP-101 50 mgExperimentalORP-101 (50 mg) once daily
Receives: Drug: ORP-101
ORP-101 100 mgExperimentalORP-101 (100 mg), once daily
Receives: Drug: ORP-101
PlaceboPlacebo comparatorMatching placebo, once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores

    Composite responders are defined as participants who met the daily response criteria for at least 50% of the days with diary entries over the 12-week interval. A participant must meet both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Average of daily stool consistency response for all reported bowel movements on the specific day: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Who Are Responders in Daily Worst Abdominal Pain Scores

    Pain responders over the interval from Weeks 1-12 are defined as those patients who meet the daily pain response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.

    Measured: Week 12

  2. Percentage of Participants Who Are Responders in Daily Stool Consistency Scores

    Stool consistency responders over the interval from Weeks 1-12 are defined as those patients who meet the daily stool consistency response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.

    Measured: Baseline to Week 12

  3. Percentage of Participants Who are Responders in IBS Global Symptom Scores

    IBS Global Symptom Score: Change from baseline for interval from Weeks 1-12: A responder is defined as a patient who has an IBS global symptom score of 0 (none) or 1 (mild) or daily IBS symptom score improved by ≥ 2.0 compared to the average in the week prior to randomization. A minimum of 60 days of diary entries over the 12-week interval is required for responders.

    Measured: Week 12

  4. Percentage of Participants Who are Responders in IBS Adequate Relief Scores

    IBS Adequate Relief: Percent of responders over the interval from Weeks 1-12. Responders are defined as those patients with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval.

    Measured: Week 12

  5. Percentage of Participants Who Are Modified Composite Responders Based on Responder Endpoints

    A modified composite responder endpoint in which a daily responder will be defined as having both: 1) Pain response: worst abdominal pain score in the past 24 hours improved ≥ 30% compared to the average in the week prior to randomization. 2) Stool consistency response: all bowel movements on the specific day must have BSFS score < 5 or the absence of a bowel movement if accompanied by ≥ 30% improvement in worst abdominal pain.

    Measured: Week 12

  6. Change from Baseline in Daily Abdominal Discomfort Scores

    Discomfort: Change from baseline in daily abdominal discomfort scores

    Measured: Week 12

  7. Change from Baseline in Daily Abdominal Bloating Scores

    Bloating: Change from baseline in daily abdominal bloating scores

    Measured: Week 12

  8. Number of Bowel Movements Per Day

    Frequency: Change from baseline in mean number of bowel movements per day

    Measured: Week 12

  9. Number of Bowel Incontinence Free Days

    Change from baseline in mean number of bowel incontinence episodes per day as well as the number of incontinence-free days

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start22 Nov 2019
  3. Primary completion4 Oct 2021
  4. Study completion4 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129619
Sponsor's protocol ID
OM-201
Status last verified
Mar 2022
First submitted
15 Oct 2019
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh P, Nee JW, Ballou S, Lee A, Loesch J, Iturrino J, Rangan V, Lembo A. ORP-101 in Irritable Bowel Syndrome With Diarrhea: A Phase II Randomized, Controlled Trial. Clin Gastroenterol Hepatol. 2026 Aug;24(8):2297-2304. doi: 10.1016/j.cgh.2026.03.012. Epub 2026 Mar 24.

    PubMed 41887552

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORP-101 in people with Irritable Bowel Syndrome With Diarrhea, run by OrphoMed, Inc. at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.

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